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    Summary
    EudraCT Number:2017-002437-36
    Sponsor's Protocol Code Number:CRO-2017-19
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002437-36
    A.3Full title of the trial
    Pilot study to evaluate the feasibility of an innovative approach to monitor patients with gastrointestinal stromal tumour treated with imatinib
    Studio pilota per valutare la fattibilità di un approccio innovativo per il monitoraggio di pazienti affetti da tumore stromale gastrointestinale e trattati con imatinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for an innovative approach for the monitoring of patients with gastrointestinal stromal tumour treated with imatinib
    Studio per la valutazione di un nuovo approccio per il monitoraggio di pazienti affetti da tumore stromale gastrointestinale e trattati con il farmaco imatinib
    A.3.2Name or abbreviated title of the trial where available
    Innovative approach to monitor GIST patients treated with imatinib
    Approccio innovativo per il monitoraggio di pazienti affetti da GIST e trattati con imatinib
    A.4.1Sponsor's protocol code numberCRO-2017-19
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCENTRO DI RIFERIMENTO ONCOLOGICO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRisorse dell'Istituto
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro di Riferimento Oncologico (CRO) IRCCS Aviano
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressVia Franco Gallini 2
    B.5.3.2Town/ cityAviano
    B.5.3.3Post code33081
    B.5.3.4CountryItaly
    B.5.4Telephone number0434 659282
    B.5.5Fax number0434 659527
    B.5.6E-maildirscienti@cro.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name GLIVEC - 100 MG 120 CAPSULE RIGIDE USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameimatinib
    D.3.2Product code [035372059]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with gastrointestinal stromal tumour
    Pazienti affetti da tumore stromale gastrointestinale
    E.1.1.1Medical condition in easily understood language
    Patients with gastrointestinal stromal tumour
    Pazienti affetti da tumore stromale gastrointestinale
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10062427
    E.1.2Term Gastrointestinal stromal tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This pilot study primarily aims to verify the feasibility of practicing the combined approach on GIST patients treated with imatinib, evaluating:
    1. The proportion of patients successfully monitored according to the protocol among the enrolled patients;
    2. The time required for Cmin determination with conventional and new strategies for a simplified sample collection (DBS and microcapillary tubes);
    3. The time required for giving the clinicians the results of the combined analysis (Cmin and ctDNA).
    Valutare la fattibilità di un nuovo approccio per il monitoraggio simultaneo delle concentrazioni plasmatiche di farmaco e dello stato mutazionale del tumore attraverso l’analisi del ctDNA con il fine di valutare eventuali variazioni nell’esposizione al farmaco ed individuare possibili marcatori precoci di resistenza al trattamento in pazienti affetti da GIST e trattati con imatinib. La fattibilità verrà valutata in termini di:
    1. Numero di pazienti monitorati con successo secondo il protocollo sul totale dei pazienti arruolati.
    2. Tempo richiesto per il TDM con la metodica convenzionale e con nuove strategie per la raccolta semplificata del campione (Dried Blood Spot (DBS) e microcapillari)
    3. Tempo necessario per fornire la risposta dell’analisi combinata Cmin-biopsia liquida ai clinici
    E.2.2Secondary objectives of the trial
    • To evaluate the possibility to early detect tumour progression through ctDNA analysis in patients’ plasma samples in course of treatment.
    • To verify the possible correlation between imatinib exposure and response (TTP), overall and by tumour mutational subtype;
    • To validate a point-of-care-testing (POCT) TDM (electrochemical biosensors and molecularly imprinted polymers);
    • Valutare la possibilità di identificare precocemente, tramite l’analisi di ctDNA, la progressione di malattia.
    • Verificare la possibile correlazione tra l’esposizione di imatinib e la risposta (in termini di tempo alla progressione) stratificando i pazienti in base allo stato mutazionale del tumore
    • Validare nuove metodiche per il TDM (biosensori elettrochimici e molecularly imprinted polymers);
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically confirmed diagnosis of metastatic GIST eligible for imatinib treatment according to the routine clinical practice criteria; Age =18; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate liver, renal and bone marrow functions; Life expectancy > 3 months; Just for patients already on-treatment with imatinib, the therapy must be initiated more than 3 months prior to the first sample collection (to reach a stable blood drug concentration); Signed informed consent and local Ethical Committee (EC) approval availability; All patients in fertile age must have been under contraceptive treatment;
    Diagnosi istologicamente o citologicamente confermata di GIST metastatico, eleggibile per trattamento con imatinib secondo i criteri della normale pratica clinica; Età maggiore di 18; Performance status (scala della Eastern Cooperative Oncology Group, ECOG) < 2, con funzionalità renale, epatica e midollare conservata; aspettativa di vita >3 mesi; Solo per pazienti già in trattamento con imatinib, la terapia dovrà essere iniziata da più di 3 mesi prima del primo prelievo ematico (per raggiungere una concentrazione stabile di farmaco nel plasma); Firma del consenso informato e approvazione del comitato etico
    E.4Principal exclusion criteria
    Pregnancy status; Refusal of informed consent; non-collaborative and/or unreliable patients; Patients who could not attend periodic clinical check-ups.
    stato di gravidanza, contraccezione non adeguata; pazienti non collaborativi e/o non affidabili; impossibilità dei pazienti ad accedere alla Struttura o di sottoporsi a periodici check-up clinici; Rifiuto del consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of patients successfully monitored according to the protocol among the enrolled patients
    2. The time required for TDM with conventional and new strategies for a simplified sample collection (DBS and microcapillary tubes)
    3. The time required for giving the clinicians the results of the combined analysis (TDM and liquid biopsy)
    1. Numero di pazienti monitorati con successo secondo il protocollo sul totale dei pazienti arruolati.
    2. Tempo richiesto per il TDM con la metodica convenzionale e con nuove strategie per la raccolta semplificata del campione (Dried Blood Spot (DBS) e microcapillari)
    3. Tempo necessario per fornire la risposta dell’analisi combinata TDM-biopsia liquida ai clinici
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 YEARS
    2 ANNI
    E.5.2Secondary end point(s)
    To evaluate the possibility to early detect tumour progression through ctDNA analysis in patients’ plasma samples in course of treatment; To verify the possible correlation between imatinib exposure and response (TTP), overall and by tumour mutational subtype; To validate a point-of-care-testing (POCT) TDM
    Valutare la possibilità di identificare precocemente, tramite l’analisi di ctDNA, la progressione di malattia; Verificare la possibile correlazione tra l’esposizione di imatinib e la risposta (TTP) nella popolazione globale e stratificando i pazienti in base allo stato mutazionale del tumore; Validare nuove metodiche per il TDM
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 anni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    innovative approach for the monitoring of patients with gastrointestinal stromal tumours treated with imatinib
    valutazione di un approccio innovativo per il monitoraggio di pazienti affetti da tumore stromale gastrointestinale e trattati con imatinib
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Italy
    Netherlands
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 58
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    FOLLOW UP
    FOLLOW UP
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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